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Recruiting Phase 4 Interventional

Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator

ClinicalTrials.gov ID: NCT06964464

Public ClinicalTrials.gov record NCT06964464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 10:46 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.

Study identification

NCT ID
NCT06964464
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
University of Rochester
Other
Enrollment
2,000 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2025
Primary completion
May 31, 2031
Completion
Jun 30, 2031
Last update posted
Sep 17, 2025

2025 – 2031

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
HonorHealth Scottsdale Arizona 85258 Recruiting
AdventHealth Redmond Rome Georgia 30165 Recruiting
AdventHealth Shawnee Mission Shawnee Mission Kansas 66204 Recruiting
Henry Ford Health System Detroit Michigan 48202 Recruiting
University of Mossouri Columbia Missouri 65212 Recruiting
Creighton University Medical Center Omaha Nebraska 68124 Recruiting
Suny Downstate Brooklyn New York 11203 Recruiting
New York-Presbyterian Brooklyn Methodist Hospital Brooklyn New York 11215 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
CHRISTUS Trinity Mother Frances Health System Tyler Texas 75701 Recruiting
Health University of Utah Salt Lake City Utah 84112 Recruiting
Virginia Commonwealth University Richmond Virginia 23298 Recruiting
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06964464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2025 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06964464 live on ClinicalTrials.gov.

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